Recruiting
Early Phase 1

Indocyanine Green

Sponsor:

University of Alabama at Birmingham

Code:

NCT07250854

Conditions

Biliary Atresia

Kasai

Cholestasis in Newborn

Cholestasis in Newborn Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Indocyanine Green

Study Details

Brief summary:

In infants that present with findings concerning for biliary atresia, along with other cholestatic work up which is standard, they will receive a one-time intravenous (IV) dose of Indocyanine Green (ICG). The infant's diapers will subsequently be examined for presence of the ICG, and if present, suggests bile flow. This was described as 97% accurate for assessing biliary patency and we would like to perform a similar study to assess biliary patency in the work up of neonatal cholestasis.

Conditions

Biliary Atresia

Kasai

Cholestasis in Newborn

Cholestasis in Newborn Infant

Study ID

NCT07250854

Start date

Jan 23, 2026

Status verified date

Nov, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Infants admitted to the hospital (no matter their age, sex, race/ethnicity) who a hepatologist deems warrants inpatient work up of neonatal cholestasis suspected to be due to biliary atresia.

Exclusion Criteria:

  • Infants that a hepatologist has not deemed to warrant inpatient admission for work up of neonatal cholestasis suspected to be due to biliary atresia.
  • Infants that are managed in the outpatient setting
  • Non-cholestatic infants
  • Patient who are on TPN AND NPO for reasons other than temporary imaging or surgical requirements
  • Infant with a history of bowel resection or other surgical procedures known to introduce blood into the gastrointestinal tract.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cholestatic infants

infants that are cholestatic needing further work up for biliary atresia

Interventions

Indocyanine Green

Optical imaging agent

Primary outcome measure

  • The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia [ Time Frame: Within 72 hours ]

Central Contacts and Locations

Central contacts

Samuel Hagman, DO, DO

2056389801sehagman@uabmc.edu

Locations

University of Alabama At Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

samuel hagman, DO

2056389801sehagman@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Feb 18, 2026

Last verified

Nov, 2025

Keywords

  • biliary atresia
  • kasai
  • cholestasis
  • cholestasis in neonate
  • cholestasis in newborn
  • direct bilirubin
  • acholic stool

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-02-18.